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This informa-conducted as recommended in the guidance.

tion should be based on the limited stability data available when the trial starts. STABILITY TESTING FOR age may be qualified by reference to prior human or ani- INVESTIGATIONAL NDAs mal data.

In recent times, America’s wars in Korea and Vietnam have also influenced the popular American psych, spawning narratives like that of Miss Saigon.“And let’s not forget Hollywood’s global influence”, says Dr Sandy To, who specialises in gender studies at Hong Kong University.

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DRUG PRODUCT • 3-month accelerated stability studies • Long-term stability studies (available data at Original ANDAs should contain stability data generatedunder the long-term and accelerated stability storage con- the time of original filing and subsequentditions delineated in V.

Extension of the An ANDA that is determined to be one of the above cat-egories should contain a modified ICH Q1A stability datapackage, including© 2004 by CRC Press LLC36 Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Productstentative expiration dating period should be based on data stability study and the test methods used to monitor thegenerated on at least three production batches tested stability of the drug product packaged in the proposedaccording to the approved protocol outlined in the stability container and closure system, and storage conditions andcommitment.



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